European Medicines Agency accepts submission to update Bexsero label for single-dose meningitis B booster in individuals aged 10 and above

GSK has recently announced that the European Medicines Agency has accepted a submission seeking to update the Bexsero label to include a single booster dose for individuals aged 10 and older who were previously vaccinated with Bexsero.

Should a one-dose booster receive approval, those who received Bexsero during childhood could be given a single additional dose from the age of 10 onwards. If widely adopted, such a booster could contribute to reducing the overall burden of Invasive Meningococcal Disease in countries that have already established infant MenB vaccination programmes.

Invasive Meningococcal Disease is a rare but potentially severe illness caused by Neisseria meningitidis. Although incidence is highest among infants and young children, a secondary peak occurs in those aged 15 to 24, frequently associated with behaviours that heighten transmission risk, including kissing, sharing drinks, and residing in shared accommodation.

The submission draws on a Phase 3b open-label, multi-centre study examining the immune response to a Bexsero booster dose in individuals aged 10 to 20 who had previously completed the full primary vaccination series during infancy. Findings from the study indicate that a single dose was effective in restoring immune responses in those originally vaccinated as infants. Complete data are set to be presented at the 25th International Pathogenic Neisseria Conference in September.

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Related Topics and Keywords

Bexsero, European Medicines Agency, meningitis B